Efficacy of add-on Danhong injection in patients with unstable angina pectoris: A double-blind, randomized, placebo-controlled, multicenter clinical trial
Danhong injection (DHI)，which is extracted from Salviae miltiorrhizae and Flos carthami，has been widely prescribed to patients with unstable angina pectoris (UAP) in China. However, a high quality clinical trial is needed. To determine whether DHI can relieve symptoms of transient myocardial ischemi...
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| Veröffentlicht in: | Journal of ethnopharmacology 2022-02, Vol.284, p.114794-114794, Article 114794 |
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| creator | Chen, Lin Fu, Guang Hua, Qi Zhu, Hai-Yan Deng, Yue Wu, Wei Zhao, Yu-Jie Yang, Xi-Yan Yang, Bai-Song Zhou, Ya-Bin Liu, Jun Yu, Ya-Nan Chen, Bing-Wei Wang, Xian Wang, Zhong |
| description | Danhong injection (DHI)，which is extracted from Salviae miltiorrhizae and Flos carthami，has been widely prescribed to patients with unstable angina pectoris (UAP) in China. However, a high quality clinical trial is needed.
To determine whether DHI can relieve symptoms of transient myocardial ischemia in patients with unstable angina pectoris.
A double-blind, placebo-controlled, randomized clinical trial was conducted in nine hospitals in China. Inpatients with UAP with blood stasis syndrome (BSS) were randomized 1:1 to receive DHI or placebo. The primary outcome was improvement rate in the quantification score of angina pectoris. Secondary outcomes included blood stasis syndrome scale, nitrates use, electrocardiogram recordings, PCI procedures, Seattle Angina Questionnaire (SAQ) and biochemical indexes.
160 participants were enrolled and 159 were analyzed. There was no significant difference in primary outcome as compared with control group at the end of 7-day treatment, but significant difference at 28-day follow up (70.53% [95% CI, 59.97–81.09%] and 54.34% [95% CI, 42.68–65.99%]; P = 0.0423). The BSS score was significantly lower in the DHI group than that in the control group at day 28 (6.49 [6.96] vs 10.53 [9.07], P = 0.0034). In addition, DHI was significantly superior to placebo in the angina stability score of SAQ (91.10 [17.37] versus 78.21 [22.08], P |
| doi_str_mv | 10.1016/j.jep.2021.114794 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2593598796</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0378874121010242</els_id><sourcerecordid>2593598796</sourcerecordid><originalsourceid>FETCH-LOGICAL-c353t-e8b9ee6567b2868a5c7dbca083d1390ec67c131b2d9534dab978ed1fb858690c3</originalsourceid><addsrcrecordid>eNp9kc1u1TAQhS1ERS-FB2CDvGRBLnacxA6sqlJ-pErdlLXln0nryLGD7RSVR-nT4qtbWLKa0fg7R-M5CL2hZE8JHT7M-xnWfUtauqe042P3DO2o4G3De86eox1hXDSCd_QUvcx5JoRw2pEX6JR1nLWs5zv0eDlNzijzgOOElbVNDPizCncx3GIXZjDF1YkLeFXFQSgZ_3LlDm8hF6U9YBVuXVB4rWBMLn_E59jGrb402rtg3-Okgo2L-w21X70yoGNjYigpen-YLZsvzlRnSNhUSV3G45Kc8q_QyaR8htdP9Qz9-HJ5c_Gtubr--v3i_KoxrGelAaFHgKEfuG7FIFRvuNVGEcEsZSMBM3BDGdWtHXvWWaVHLsDSSYteDCMx7Ay9O_quKf7cIBe5uGzAexUgblm2_cj6UfBxqCg9oibFnBNMck1uUelBUiIPkchZ1kjkIRJ5jKRq3j7Zb3oB-0_xN4MKfDoCUD957yDJbOqpDViX6lmlje4_9n8ANt6e9A</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2593598796</pqid></control><display><type>article</type><title>Efficacy of add-on Danhong injection in patients with unstable angina pectoris: A double-blind, randomized, placebo-controlled, multicenter clinical trial</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><creator>Chen, Lin ; Fu, Guang ; Hua, Qi ; Zhu, Hai-Yan ; Deng, Yue ; Wu, Wei ; Zhao, Yu-Jie ; Yang, Xi-Yan ; Yang, Bai-Song ; Zhou, Ya-Bin ; Liu, Jun ; Yu, Ya-Nan ; Chen, Bing-Wei ; Wang, Xian ; Wang, Zhong</creator><creatorcontrib>Chen, Lin ; Fu, Guang ; Hua, Qi ; Zhu, Hai-Yan ; Deng, Yue ; Wu, Wei ; Zhao, Yu-Jie ; Yang, Xi-Yan ; Yang, Bai-Song ; Zhou, Ya-Bin ; Liu, Jun ; Yu, Ya-Nan ; Chen, Bing-Wei ; Wang, Xian ; Wang, Zhong</creatorcontrib><description>Danhong injection (DHI)，which is extracted from Salviae miltiorrhizae and Flos carthami，has been widely prescribed to patients with unstable angina pectoris (UAP) in China. However, a high quality clinical trial is needed.
To determine whether DHI can relieve symptoms of transient myocardial ischemia in patients with unstable angina pectoris.
A double-blind, placebo-controlled, randomized clinical trial was conducted in nine hospitals in China. Inpatients with UAP with blood stasis syndrome (BSS) were randomized 1:1 to receive DHI or placebo. The primary outcome was improvement rate in the quantification score of angina pectoris. Secondary outcomes included blood stasis syndrome scale, nitrates use, electrocardiogram recordings, PCI procedures, Seattle Angina Questionnaire (SAQ) and biochemical indexes.
160 participants were enrolled and 159 were analyzed. There was no significant difference in primary outcome as compared with control group at the end of 7-day treatment, but significant difference at 28-day follow up (70.53% [95% CI, 59.97–81.09%] and 54.34% [95% CI, 42.68–65.99%]; P = 0.0423). The BSS score was significantly lower in the DHI group than that in the control group at day 28 (6.49 [6.96] vs 10.53 [9.07], P = 0.0034). In addition, DHI was significantly superior to placebo in the angina stability score of SAQ (91.10 [17.37] versus 78.21 [22.08], P < 0.001). There were no significant differences in other secondary outcome measures.
A small decrease in the total effective rate and an increase in the angina stability score were observed 28 days after implementation of DHI in UAP with a total blood stasis syndrome score decrease, but the efficacy was not observed at day 7. The findings support that DHI may potentially relieve clinical symptoms and can benefit angina stability.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02007187.
[Display omitted]</description><identifier>ISSN: 0378-8741</identifier><identifier>EISSN: 1872-7573</identifier><identifier>DOI: 10.1016/j.jep.2021.114794</identifier><identifier>PMID: 34732357</identifier><language>eng</language><publisher>Ireland: Elsevier B.V</publisher><subject>Adult ; Aged ; Angina, Unstable - drug therapy ; Cardiovascular Agents - administration & dosage ; Cardiovascular Agents - therapeutic use ; Chinese herbal injections ; Double-Blind Method ; Drugs, Chinese Herbal - administration & dosage ; Drugs, Chinese Herbal - therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Myocardial ischemia ; Phytotherapy ; Quality of life ; Randomized controlled trial ; Unstable angina pectoris</subject><ispartof>Journal of ethnopharmacology, 2022-02, Vol.284, p.114794-114794, Article 114794</ispartof><rights>2021 Elsevier B.V.</rights><rights>Copyright © 2021 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c353t-e8b9ee6567b2868a5c7dbca083d1390ec67c131b2d9534dab978ed1fb858690c3</citedby><cites>FETCH-LOGICAL-c353t-e8b9ee6567b2868a5c7dbca083d1390ec67c131b2d9534dab978ed1fb858690c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jep.2021.114794$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34732357$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chen, Lin</creatorcontrib><creatorcontrib>Fu, Guang</creatorcontrib><creatorcontrib>Hua, Qi</creatorcontrib><creatorcontrib>Zhu, Hai-Yan</creatorcontrib><creatorcontrib>Deng, Yue</creatorcontrib><creatorcontrib>Wu, Wei</creatorcontrib><creatorcontrib>Zhao, Yu-Jie</creatorcontrib><creatorcontrib>Yang, Xi-Yan</creatorcontrib><creatorcontrib>Yang, Bai-Song</creatorcontrib><creatorcontrib>Zhou, Ya-Bin</creatorcontrib><creatorcontrib>Liu, Jun</creatorcontrib><creatorcontrib>Yu, Ya-Nan</creatorcontrib><creatorcontrib>Chen, Bing-Wei</creatorcontrib><creatorcontrib>Wang, Xian</creatorcontrib><creatorcontrib>Wang, Zhong</creatorcontrib><title>Efficacy of add-on Danhong injection in patients with unstable angina pectoris: A double-blind, randomized, placebo-controlled, multicenter clinical trial</title><title>Journal of ethnopharmacology</title><addtitle>J Ethnopharmacol</addtitle><description>Danhong injection (DHI)，which is extracted from Salviae miltiorrhizae and Flos carthami，has been widely prescribed to patients with unstable angina pectoris (UAP) in China. However, a high quality clinical trial is needed.
To determine whether DHI can relieve symptoms of transient myocardial ischemia in patients with unstable angina pectoris.
A double-blind, placebo-controlled, randomized clinical trial was conducted in nine hospitals in China. Inpatients with UAP with blood stasis syndrome (BSS) were randomized 1:1 to receive DHI or placebo. The primary outcome was improvement rate in the quantification score of angina pectoris. Secondary outcomes included blood stasis syndrome scale, nitrates use, electrocardiogram recordings, PCI procedures, Seattle Angina Questionnaire (SAQ) and biochemical indexes.
160 participants were enrolled and 159 were analyzed. There was no significant difference in primary outcome as compared with control group at the end of 7-day treatment, but significant difference at 28-day follow up (70.53% [95% CI, 59.97–81.09%] and 54.34% [95% CI, 42.68–65.99%]; P = 0.0423). The BSS score was significantly lower in the DHI group than that in the control group at day 28 (6.49 [6.96] vs 10.53 [9.07], P = 0.0034). In addition, DHI was significantly superior to placebo in the angina stability score of SAQ (91.10 [17.37] versus 78.21 [22.08], P < 0.001). There were no significant differences in other secondary outcome measures.
A small decrease in the total effective rate and an increase in the angina stability score were observed 28 days after implementation of DHI in UAP with a total blood stasis syndrome score decrease, but the efficacy was not observed at day 7. The findings support that DHI may potentially relieve clinical symptoms and can benefit angina stability.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02007187.
[Display omitted]</description><subject>Adult</subject><subject>Aged</subject><subject>Angina, Unstable - drug therapy</subject><subject>Cardiovascular Agents - administration & dosage</subject><subject>Cardiovascular Agents - therapeutic use</subject><subject>Chinese herbal injections</subject><subject>Double-Blind Method</subject><subject>Drugs, Chinese Herbal - administration & dosage</subject><subject>Drugs, Chinese Herbal - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial ischemia</subject><subject>Phytotherapy</subject><subject>Quality of life</subject><subject>Randomized controlled trial</subject><subject>Unstable angina pectoris</subject><issn>0378-8741</issn><issn>1872-7573</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc1u1TAQhS1ERS-FB2CDvGRBLnacxA6sqlJ-pErdlLXln0nryLGD7RSVR-nT4qtbWLKa0fg7R-M5CL2hZE8JHT7M-xnWfUtauqe042P3DO2o4G3De86eox1hXDSCd_QUvcx5JoRw2pEX6JR1nLWs5zv0eDlNzijzgOOElbVNDPizCncx3GIXZjDF1YkLeFXFQSgZ_3LlDm8hF6U9YBVuXVB4rWBMLn_E59jGrb402rtg3-Okgo2L-w21X70yoGNjYigpen-YLZsvzlRnSNhUSV3G45Kc8q_QyaR8htdP9Qz9-HJ5c_Gtubr--v3i_KoxrGelAaFHgKEfuG7FIFRvuNVGEcEsZSMBM3BDGdWtHXvWWaVHLsDSSYteDCMx7Ay9O_quKf7cIBe5uGzAexUgblm2_cj6UfBxqCg9oibFnBNMck1uUelBUiIPkchZ1kjkIRJ5jKRq3j7Zb3oB-0_xN4MKfDoCUD957yDJbOqpDViX6lmlje4_9n8ANt6e9A</recordid><startdate>20220210</startdate><enddate>20220210</enddate><creator>Chen, Lin</creator><creator>Fu, Guang</creator><creator>Hua, Qi</creator><creator>Zhu, Hai-Yan</creator><creator>Deng, Yue</creator><creator>Wu, Wei</creator><creator>Zhao, Yu-Jie</creator><creator>Yang, Xi-Yan</creator><creator>Yang, Bai-Song</creator><creator>Zhou, Ya-Bin</creator><creator>Liu, Jun</creator><creator>Yu, Ya-Nan</creator><creator>Chen, Bing-Wei</creator><creator>Wang, Xian</creator><creator>Wang, Zhong</creator><general>Elsevier B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20220210</creationdate><title>Efficacy of add-on Danhong injection in patients with unstable angina pectoris: A double-blind, randomized, placebo-controlled, multicenter clinical trial</title><author>Chen, Lin ; Fu, Guang ; Hua, Qi ; Zhu, Hai-Yan ; Deng, Yue ; Wu, Wei ; Zhao, Yu-Jie ; Yang, Xi-Yan ; Yang, Bai-Song ; Zhou, Ya-Bin ; Liu, Jun ; Yu, Ya-Nan ; Chen, Bing-Wei ; Wang, Xian ; Wang, Zhong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c353t-e8b9ee6567b2868a5c7dbca083d1390ec67c131b2d9534dab978ed1fb858690c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Angina, Unstable - drug therapy</topic><topic>Cardiovascular Agents - administration & dosage</topic><topic>Cardiovascular Agents - therapeutic use</topic><topic>Chinese herbal injections</topic><topic>Double-Blind Method</topic><topic>Drugs, Chinese Herbal - administration & dosage</topic><topic>Drugs, Chinese Herbal - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myocardial ischemia</topic><topic>Phytotherapy</topic><topic>Quality of life</topic><topic>Randomized controlled trial</topic><topic>Unstable angina pectoris</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chen, Lin</creatorcontrib><creatorcontrib>Fu, Guang</creatorcontrib><creatorcontrib>Hua, Qi</creatorcontrib><creatorcontrib>Zhu, Hai-Yan</creatorcontrib><creatorcontrib>Deng, Yue</creatorcontrib><creatorcontrib>Wu, Wei</creatorcontrib><creatorcontrib>Zhao, Yu-Jie</creatorcontrib><creatorcontrib>Yang, Xi-Yan</creatorcontrib><creatorcontrib>Yang, Bai-Song</creatorcontrib><creatorcontrib>Zhou, Ya-Bin</creatorcontrib><creatorcontrib>Liu, Jun</creatorcontrib><creatorcontrib>Yu, Ya-Nan</creatorcontrib><creatorcontrib>Chen, Bing-Wei</creatorcontrib><creatorcontrib>Wang, Xian</creatorcontrib><creatorcontrib>Wang, Zhong</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of ethnopharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chen, Lin</au><au>Fu, Guang</au><au>Hua, Qi</au><au>Zhu, Hai-Yan</au><au>Deng, Yue</au><au>Wu, Wei</au><au>Zhao, Yu-Jie</au><au>Yang, Xi-Yan</au><au>Yang, Bai-Song</au><au>Zhou, Ya-Bin</au><au>Liu, Jun</au><au>Yu, Ya-Nan</au><au>Chen, Bing-Wei</au><au>Wang, Xian</au><au>Wang, Zhong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of add-on Danhong injection in patients with unstable angina pectoris: A double-blind, randomized, placebo-controlled, multicenter clinical trial</atitle><jtitle>Journal of ethnopharmacology</jtitle><addtitle>J Ethnopharmacol</addtitle><date>2022-02-10</date><risdate>2022</risdate><volume>284</volume><spage>114794</spage><epage>114794</epage><pages>114794-114794</pages><artnum>114794</artnum><issn>0378-8741</issn><eissn>1872-7573</eissn><abstract>Danhong injection (DHI)，which is extracted from Salviae miltiorrhizae and Flos carthami，has been widely prescribed to patients with unstable angina pectoris (UAP) in China. However, a high quality clinical trial is needed.
To determine whether DHI can relieve symptoms of transient myocardial ischemia in patients with unstable angina pectoris.
A double-blind, placebo-controlled, randomized clinical trial was conducted in nine hospitals in China. Inpatients with UAP with blood stasis syndrome (BSS) were randomized 1:1 to receive DHI or placebo. The primary outcome was improvement rate in the quantification score of angina pectoris. Secondary outcomes included blood stasis syndrome scale, nitrates use, electrocardiogram recordings, PCI procedures, Seattle Angina Questionnaire (SAQ) and biochemical indexes.
160 participants were enrolled and 159 were analyzed. There was no significant difference in primary outcome as compared with control group at the end of 7-day treatment, but significant difference at 28-day follow up (70.53% [95% CI, 59.97–81.09%] and 54.34% [95% CI, 42.68–65.99%]; P = 0.0423). The BSS score was significantly lower in the DHI group than that in the control group at day 28 (6.49 [6.96] vs 10.53 [9.07], P = 0.0034). In addition, DHI was significantly superior to placebo in the angina stability score of SAQ (91.10 [17.37] versus 78.21 [22.08], P < 0.001). There were no significant differences in other secondary outcome measures.
A small decrease in the total effective rate and an increase in the angina stability score were observed 28 days after implementation of DHI in UAP with a total blood stasis syndrome score decrease, but the efficacy was not observed at day 7. The findings support that DHI may potentially relieve clinical symptoms and can benefit angina stability.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02007187.
[Display omitted]</abstract><cop>Ireland</cop><pub>Elsevier B.V</pub><pmid>34732357</pmid><doi>10.1016/j.jep.2021.114794</doi><tpages>1</tpages></addata></record> |
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| subjects | Adult Aged Angina, Unstable - drug therapy Cardiovascular Agents - administration & dosage Cardiovascular Agents - therapeutic use Chinese herbal injections Double-Blind Method Drugs, Chinese Herbal - administration & dosage Drugs, Chinese Herbal - therapeutic use Female Humans Male Middle Aged Myocardial ischemia Phytotherapy Quality of life Randomized controlled trial Unstable angina pectoris |
| title | Efficacy of add-on Danhong injection in patients with unstable angina pectoris: A double-blind, randomized, placebo-controlled, multicenter clinical trial |
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